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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K060315
Device Name HEALTHSTATS BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
Applicant
HEALTHSTATS INTERNATIONAL PTE. LTD.
S65 W35739 PIPER ROAD
EAGLE,  WI  53119
Applicant Contact STEPHEN GORSKI
Correspondent
HEALTHSTATS INTERNATIONAL PTE. LTD.
S65 W35739 PIPER ROAD
EAGLE,  WI  53119
Correspondent Contact STEPHEN GORSKI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/08/2006
Decision Date 04/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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